The Centers for Medicare and Medicaid Services (CMS) are required to cover medical services deemed reasonable and necessary for its beneficiaries.1 While most services are covered without controversy, a small fraction receive additional scrutiny, formalized in national coverage decisions that dictate the terms of coverage for services considered to be particularly important. Some novel treatments require enrollment in a research study intended to generate evidence specific to patients receiving Medicare benefits, a process known as coverage with evidence development (CED).2 However, recent decision making by CMS calls into question the application of the CED pathway for patients with pacemakers or implantable cardioverter-defibrillators (ICDs) who require magnetic resonance imaging (MRI). We argue that current CMS policy for patients with capped or epicardial leads needlessly restricts access to potentially life-changing treatment, while also limiting investigators’ ability to gather further evidence for clinical care and Medicare coverage.
Kramer DB, Lo B, Russo RJ. Implications of Medicare Coverage for Magnetic Resonance Imaging in Patients With Capped or Epicardial Leads. JAMA Cardiol. Published online November 14, 2018. doi:10.1001/jamacardio.2018.3820
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